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Table 1 Inclusion & exclusion criteria anthroposophic supportive therapy study

From: Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up

Inclusion Criteria:

• Age between 1 year and 18 years

• Morphologically and/or immunologically

• confirmed diagnosis of a following disease:

Hodgkin's disease (EuroNET-PHL-C1)

Acute lymphoblastic leukemia (ALL);

(ALL- BFM 2000; ALL-BFM 2000 incl. EsPhALL)

ALL (COALL 07-03)

Relapse of ALL (ALL-Rez BFM 2002)

Acute myeloid leukemia (AML) (AML-BFM 2004)

Nephroblastoma (SIOP 2001 / GPOH)

Germ cell tumors MAKEI 96

Mature B-NHL / B-ALL (B-NHL - BFM 04; B- NHL

BFM Rituximab)

Lymphoblastic lymphoma (until 06/2008

Euro-LB-02; from 07/2008 NHL-BFM 90)

Medulloblastoma / PNET or

Ependymoma (HIT 2000)

Brain tumors-highly malignant

(gliomas HIT-GBM-D; until 05/2009)

Neuroblastoma (NB 2004 and

NB 2004 HR)

Osteosarcoma (EURAMOS 1)

Ewing's sarcoma (until 09/2009 EURO-

E.W.I.N.G '99; from 10/2009 EWING 2008)

Rhabdomyosarcoma (CWS 2002P;

until 6/2009)

• Protocol-compliant therapy for the included diseases

• Treatment in one of the study centers

• Patients must be available during the treatment period and be able to comply with the study plan

• Written consent for participation from the patient or the legal guardian

Exclusion Criteria:

• Serious pre-existing/

co-existing psychiatric illness

• Other existing serious medical

condition that could interfere

with the patient’s ability to

receive trial- appropriate therapy

• Any other condition or therapy that,

in the opinion of the treating physician,

could pose a risk to the patient or interfere

with the objectives of the study

• Absence of or incomplete informed

consent form

• Known allergies to any component of the

study medications

• Pregnancy or not using effective contraception (hormonal contraception, barrier)

• Other experimental treatment during or within this study (including chemotherapeutic drugs or immunotherapies not listed in the protocol)